Rare Tumor: Stromal Ovarian
- Malignant Ovarian Surface Epithelial-Stromal Tumor
GOG 264 — A Randomized Phase II Trial of Paclitaxel and Carboplatin vs. Bleomycin, Etoposide, and Cisplatin for Newly Diagnosed Advanced State and Recurrent Chemonaive Sex Cord-Stromal Tumors of the Ovary
Link to Full Details:
This randomized phase II trial is studying paclitaxel and carboplatin to see how well they work compared with bleomycin sulfate, etoposide phosphate, and cisplatin in treating patients with advanced or recurrent sex cord-ovarian stromal tumors. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective in treating sex cord-ovarian stromal tumors.
Female – 18 years and older
- Newly diagnosed ovarian stromal tumor, Stage IIA – IV disease
- Entered within 8 weeks from surgery
- GOG PS 0-2
- Either measurable residual disease by RECIST criteria, or they may have no measurable residual disease; OR, they must have biopsy-proven recurrent disease of any stage and have never received cytotoxic chemotherapy
- See full list of inclusion criteria at clinicaltrials.gov
- Prior cytotoxic chemotherapy or biologics for sex cord-stromal tumors
- See full list of exclusion criteria at clinicaltrials.gov
Arm I: Paclitaxel 175 mg/m² IV over 3 hr + Carboplatin AUC 6, every 3 weeks x 6 cycles.
Arm II: Bleomycin 20 units/m² IVP D1 + Etoposide 76 mg/m² IV D1-5 + Cisplatin 20 mg/m² D1-5, every 3 weeks x 4 cycles. Supplied: NONE.
Patients who have received prior radiation therapy will receive etoposide 60 mg/m2 on Days 1-4 only